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RU2017117856A - OPTIONS OF THE Fc REGION WITH MODIFIED FcRn BINDING AND METHODS OF APPLICATION - Google Patents

OPTIONS OF THE Fc REGION WITH MODIFIED FcRn BINDING AND METHODS OF APPLICATION Download PDF

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RU2017117856A
RU2017117856A RU2017117856A RU2017117856A RU2017117856A RU 2017117856 A RU2017117856 A RU 2017117856A RU 2017117856 A RU2017117856 A RU 2017117856A RU 2017117856 A RU2017117856 A RU 2017117856A RU 2017117856 A RU2017117856 A RU 2017117856A
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Эккехард Мёсснер
Тильман ШЛОТАУЭР
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Ф. Хоффманн-Ля Рош Аг
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Claims (73)

1. Fc-область класса IgG, содержащая первый полипептид вариантной Fc-области и второй полипептид вариантной Fc-области,1. The Fc region of the IgG class containing the first polypeptide of the variant Fc region and the second polypeptide of the variant Fc region, при этом:wherein: a) первый полипептид вариантной Fc-области происходит из первого полипептида родительской Fc-области класса IgG, а второй полипептид вариантной Fc-области происходит из второго полипептида родительской Fc-области класса IgG, вследствие чего первый полипептид родительской Fc-области класса IgG идентичен второму полипептиду или отличается от второго полипептида родительской Fc-области класса IgG, иa) the first polypeptide of the variant Fc region originates from the first polypeptide of the parent IgG class Fc region, and the second polypeptide of the variant Fc region originates from the second polypeptide of the parent IgG class Fc region, whereby the first polypeptide of the parent IgG class Fc region is identical to the second polypeptide or different from the second polypeptide of the parent Fc region of the IgG class, and b) первый полипептид вариантной Fc-области отличается от второго полипептида вариантной Fc-области по одному или более аминокислотным остаткам, отличающимся от тех аминокислотных остатков, по которым первый полипептид родительской Fc-области класса IgG отличается от второго полипептида родительской Fc-области класса IgG, иb) the first polypeptide of the variant Fc region is different from the second polypeptide of the variant Fc region in one or more amino acid residues different from those amino acid residues in which the first polypeptide of the parent Fc region of the IgG class is different from the second polypeptide of the parent Fc region of the IgG class and c) Fc-область класса IgG, содержащая первый полипептид вариантной Fc-области и второй полипептид вариантной Fc-области, обладает аффинностью к Fc-рецептору человека, которая отличается от таковой у Fc-области класса IgG, содержащей первый полипептид родительской Fc-области класса IgG по пункту (a) и второй полипептид родительской Fc-области класса IgG по пункту (a),c) the IgG class Fc region containing the first polypeptide of the variant Fc region and the second polypeptide of the variant Fc region has an affinity for the human Fc receptor that is different from that of the IgG class Fc region containing the first polypeptide of the parent Fc region of the class IgG according to (a) and a second polypeptide of the parent IgG class Fc region according to (a), при этом либо первый полипептид Fc-области, либо второй полипептид Fc-области, либо оба полипептида Fc-области содержат независимо друг от друга одну из приведенных ниже мутаций или комбинаций мутаций:wherein either the first polypeptide of the Fc region, or the second polypeptide of the Fc region, or both polypeptides of the Fc region independently contain one of the following mutations or combinations of mutations: - T307H, или- T307H, or - Q311H, или- Q311H, or - E430H, или- E430H, or - N434H, или- N434H, or - T307H и Q311H, или- T307H and Q311H, or - T307H и E430H, или- T307H and E430H, or - T307H и N434A, или- T307H and N434A, or - T307H и N434H, или- T307H and N434H, or - T307Q и Q311H, или- T307Q and Q311H, or - T307Q и E430H, или- T307Q and E430H, or - T307Q и N434H, или- T307Q and N434H, or - T307H, и Q311H, и E430H, и N434A, или- T307H, and Q311H, and E430H, and N434A, or - T307H, и Q311H, и E430H, и N434H, или- T307H, and Q311H, and E430H, and N434H, or - T307H, и Q311H, и E430H, и N434Y, или- T307H, and Q311H, and E430H, and N434Y, or - T307Q, и Q311H, и E430H, и N434A, или- T307Q, and Q311H, and E430H, and N434A, or - T307Q, и Q311H, и E430H, и N434H, или- T307Q, and Q311H, and E430H, and N434H, or - T307Q, и Q311H, и E430H, и N434Y, или- T307Q, and Q311H, and E430H, and N434Y, or - T307Q, и V308P, и N434Y, и Y436H, или- T307Q, and V308P, and N434Y, and Y436H, or - T307H, и M252Y, и S254T, и T256E или - T307H, and M252Y, and S254T, and T256E, or - T307Q, и M252Y, и S254T, и T256E, или- T307Q, and M252Y, and S254T, and T256E, or - Q311H, и M252Y, и S254T, и T256E, или- Q311H, and M252Y, and S254T, and T256E, or - E430H, и M252Y, и S254T, и T256E, или- E430H, and M252Y, and S254T, and T256E, or - N434H, и M252Y, и S254T, и T256E, или- N434H, and M252Y, and S254T, and T256E, or - T307H, и Q311H, и M252Y, и S254T, и T256E, или- T307H, and Q311H, and M252Y, and S254T, and T256E, or - T307H, и E430H, и M252Y, и S254T, и T256E, или- T307H, and E430H, and M252Y, and S254T, and T256E, or - T307H, и N434A, и M252Y, и S254T, и T256E, или- T307H, and N434A, and M252Y, and S254T, and T256E, or - T307H, и N434H, и M252Y, и S254T, и T256E, или- T307H, and N434H, and M252Y, and S254T, and T256E, or - T307Q, и Q311H, и M252Y, и S254T, и T256E, или- T307Q, and Q311H, and M252Y, and S254T, and T256E, or - T307Q, и E430H, и M252Y, и S254T, и T256E, или- T307Q, and E430H, and M252Y, and S254T, and T256E, or - T307Q, и N434H, и M252Y, и S254T, и T256E, или- T307Q, and N434H, and M252Y, and S254T, and T256E, or - T307H, и Q311H, и E430H, и N434A, и M252Y, и S254T, и T256E, или- T307H, and Q311H, and E430H, and N434A, and M252Y, and S254T, and T256E, or - T307H, и Q311H, и E430H, и N434H, и M252Y, и S254T, и T256E, или- T307H, and Q311H, and E430H, and N434H, and M252Y, and S254T, and T256E, or - T307H, и Q311H, и E430H, и N434Y, и M252Y, и S254T, и T256E, или- T307H, and Q311H, and E430H, and N434Y, and M252Y, and S254T, and T256E, or - T307Q, и Q311H, и E430H, и N434A, и M252Y, и S254T, и T256E, или- T307Q, and Q311H, and E430H, and N434A, and M252Y, and S254T, and T256E, or - T307Q, и Q311H, и E430H, и N434H, и M252Y, и S254T, и T256E, или- T307Q, and Q311H, and E430H, and N434H, and M252Y, and S254T, and T256E, or - T307Q, и Q311H, и E430H, и N434Y, и M252Y, и S254T, и T256E, или- T307Q, and Q311H, and E430H, and N434Y, and M252Y, and S254T, and T256E, or - T307Q, и V308P, и N434Y, и Y436H, и M252Y, и S254T, и T256E.- T307Q, and V308P, and N434Y, and Y436H, and M252Y, and S254T, and T256E. 2. Fc-область класса IgG по п. 1, где Fc-рецептор человека представляет собой неонатальный Fc-рецептор человека.2. The Fc region of the IgG class according to claim 1, wherein the human Fc receptor is a neonatal human Fc receptor. 3. Fc-область класса IgG по любому из пп. 1-2, где те аминокислотные остатки, по которым первый полипептид родительской Fc-области класса IgG отличается от второго полипептида родительской Fc-области класса IgG, стимулируют образование гетеродимерной Fc-области класса IgG.3. The Fc region of the IgG class according to any one of paragraphs. 1-2, where those amino acid residues in which the first polypeptide of the parent IgG class Fc region is different from the second polypeptide of the parent IgG class Fc region stimulate the formation of a heterodimeric IgG class Fc region. 4. Fc-область класса IgG по любому из пп. 1-3, где:4. The Fc region of the IgG class according to any one of paragraphs. 1-3, where: 1) первый полипептид родительской Fc-области класса IgG выбран из группы, содержащей полипептид Fc-области человеческого IgG1, полипептид Fc-области человеческого IgG2, полипептид Fc-области человеческого IgG3, полипептид Fc-области человеческого IgG4, полипептид Fc-области человеческого IgG1 с мутациями L234A, L235A, полипептид Fc-области человеческого IgG1 с мутациями Y349C, T366S, L368A, Y407V, полипептид Fc-области человеческого IgG1 с мутациями L234A, L235A, Y349C, T366S, L368A, Y407V, полипептид Fc-области человеческого IgG1 с мутацией P329G, полипептид Fc-области человеческого IgG1 с мутациями L234A, L235A, P329G, полипептид Fc-области человеческого IgG1 с мутациями P329G, Y349C, T366S, L368A, Y407V, полипептид Fc-области человеческого IgG1 с мутациями L234A, L235A, P329G, Y349C, T366S, L368A, Y407V, полипептид Fc-области человеческого IgG4 с мутациями S228P, L235E, полипептид Fc-области человеческого IgG4 с мутациями S228P, L235E, P329G, полипептид Fc-области человеческого IgG4 с мутациями Y349C, T366S, L368A, Y407V, полипептид Fc-области человеческого IgG4 с мутациями S228P, L235E, Y349C, T366S, L368A, Y407V, полипептид Fc-области человеческого IgG4 с мутацией P329G, полипептид Fc-области человеческого IgG4 с мутациями P329G, Y349C, T366S, L368A, Y407V, полипептид Fc-области человеческого IgG4 с мутациями S228P, L235E, P329G, Y349C, T366S, L368A, Y407V, человеческий IgG1, IgG2 или IgG4 с мутацией K392D и человеческий IgG3 с мутацией N392D,1) the first polypeptide of the parent IgG class Fc region is selected from the group consisting of a human IgG1 Fc region polypeptide, human IgG2 Fc region polypeptide, human IgG3 Fc region polypeptide, human IgG4 Fc region polypeptide, and human IgG1 Fc region polypeptide mutations L234A, L235A, Fc region polypeptide of human IgG1 with mutations Y349C, T366S, L368A, Y407V, Fc polypeptide of human IgG1 with mutations L234A, L235A, Y349C, T366S, human polypeptide G1 IgG Pc F1 , Fc region polypeptide of human IgG1 with mutations L234A, L 235A, P329G, Fc region polypeptide of human IgG1 with mutations P329G, Y349C, T366S, L368A, Y407V, polypeptide of the Fc region of human IgG1 with mutations L234A, L235A, P329G, Y349C, T366S, L368A, IgGc F4VV with mutations S228P, L235E, human IgG4 Fc region polypeptide with mutations S228P, L235E, P329G, human IgG4 Fc region polypeptide with Y349C, T366S, L368A, Y407V mutations, human IgG4 Fc region polypeptide with S228P, L235E mutations T366S, L368A, Y407V, Fc region polypeptide of human IgG4 with P329G mutation, polypeptide of Fc region of human IgG4 with mutations P329G, Y349C, T366S, L368A, Y407V, polypeptide human IgG4 Fc region with mutations S228P, L235E, P329G, Y349C, T366S, L368A, Y407V, human IgG1, IgG2 or IgG4 with K392D mutation and human IgG3 with N392D mutation, иand 2) второй полипептид родительской Fc-области класса IgG выбран из группы, содержащей полипептид Fc-области человеческого IgG1, полипептид Fc-области человеческого IgG2, полипептид Fc-области человеческого IgG3, полипептид Fc-области человеческого IgG4, полипептид Fc-области человеческого IgG1 с мутациями L234A, L235A, полипептид Fc-области человеческого IgG1 с мутациями S354C, T366W, полипептид Fc-области человеческого IgG1 с мутациями L234A, L235A, S354C, T366W, полипептид Fc-области человеческого IgG1 с мутацией P329G, полипептид Fc-области человеческого IgG1 с мутациями L234A, L235A, P329G, полипептид Fc-области человеческого IgG1 с мутациями P329G, S354C, T366W, полипептид Fc-области человеческого IgG1 с мутациями L234A, L235A, P329G, S354C, T366W, полипептид Fc-области человеческого IgG4 с мутациями S228P, L235E, полипептид Fc-области человеческого IgG4 с мутациями S228P, L235E, P329G, полипептид Fc-области человеческого IgG4 с мутациями S354C, T366W, полипептид Fc-области человеческого IgG4 с мутациями S228P, L235E, S354C, T366W, полипептид Fc-области человеческого IgG4 с мутацией P329G, полипептид Fc-области человеческого IgG4 с мутациями P329G, S354C, T366W, полипептид Fc-области человеческого IgG4 с мутациями S228P, L235E, P329G, S354C, T366W, человеческий IgG1 с мутациями D399K, D356K и/или E357K и человеческий IgG2, IgG3 или IgG4 с мутациями D399K, E356K и/или E357K.2) the second polypeptide of the parent IgG class Fc region is selected from the group consisting of a human IgG1 Fc region polypeptide, human IgG2 Fc region polypeptide, human IgG3 Fc region polypeptide, human IgG4 Fc region polypeptide, and human IgG1 Fc region polypeptide mutations L234A, L235A, Fc region polypeptide of human IgG1 with mutations S354C, T366W, Fc region polypeptide of human IgG1 with mutations L234A, L235A, S354C, T366W, polypeptide of human IgG1 Fc region with mutation P329G, F32 polypeptide F32 mutations L234A, L235A, P329G, polypep id of human IgG1 Fc region with mutations P329G, S354C, T366W, polypeptide of human IgG1 Fc region with mutations L234A, L235A, P329G, S354C, T366W, human IgG4 Fc region polypeptide with mutations S228P, L235E, Fc Ig4 region polypeptide Fc with mutations S228P, L235E, P329G, human IgG4 Fc region polypeptide with mutations S354C, T366W, human IgG4 Fc region polypeptide with S228P, L235E, S354C, T366W mutations, human IgG4 Fc region polypeptide with P329G mutation polypeptide, human IgG4 with mutations P329G, S354C, T366W, Fc region polypeptide of human IgG4 with mutations S228P, L235E, P329G , S354C, T366W, human IgG1 with mutations D399K, D356K and / or E357K and human IgG2, IgG3 or IgG4 with mutations D399K, E356K and / or E357K. 5. Fc-область класса IgG по любому из пп. 1-4, где:5. The Fc region of the IgG class according to any one of paragraphs. 1-4, where: 1) первый полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG1, и второй полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG1, или1) the first polypeptide of the parent IgG class Fc region is the polypeptide of the human IgG1 Fc region, and the second polypeptide of the parent IgG class Fc region is the polypeptide of the human IgG1 Fc region, or 2) первый полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG1 с мутациями L234A, L235A, и второй полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG1 с мутациями L234A, L235A, или2) the first polypeptide of the parent IgG class Fc region is a polypeptide of the human IgG1 Fc region with mutations L234A, L235A, and the second polypeptide of the parent IgG class Fc region is a polypeptide of the IgG class parent Fc region with mutations L234A, L235A, or 3) первый полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG1 с мутациями L234A, L235A, P329G, и второй полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG1 с мутациями L234A, L235A, P329G, или3) the first polypeptide of the parent IgG class Fc region is a polypeptide of the human IgG1 Fc region with mutations L234A, L235A, P329G, and the second polypeptide of the parent IgG class Fc region is a polypeptide of the IgG class parent Fc region with mutations L234A, L235A, P329G , or 4) первый полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG1 с мутациями L234A, L235A, S354C, T366W, а второй полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG1 с мутациями L234A, L235A, Y349C, T366S, L368A, Y407V, или4) the first polypeptide of the parent IgG class Fc region is a human IgG1 Fc region polypeptide with mutations L234A, L235A, S354C, T366W, and the second IgG class parent Fc region polypeptide is a human IgG1 Fc region polypeptide with mutations L234A, L235A , Y349C, T366S, L368A, Y407V, or 5) первый полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG1 с мутациями L234A, L235A, P329G, S354C, T366W, а второй полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG1 с мутациями L234A, L235A, P329G, Y349C, T366S, L368A, Y407V, или5) the first IgG class Fc region parent polypeptide is a human IgG1 Fc region polypeptide with mutations L234A, L235A, P329G, S354C, T366W, and the second IgG class parent Fc region polypeptide is a human IgG1 Fc region polypeptide with mutations L234A , L235A, P329G, Y349C, T366S, L368A, Y407V, or 6) первый полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG4, и второй полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG4, или6) the first polypeptide of the parent IgG class Fc region is the polypeptide of the human IgG4 Fc region, and the second polypeptide of the parent IgG class Fc region is the polypeptide of the human IgG4 Fc region, or 7) первый полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG4 с мутациями S228P, L235E, и второй полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG4 с мутациями S228P, L235E, или7) the first polypeptide of the parent IgG4 class Fc region is the polypeptide of the human IgG4 Fc region with mutations S228P, L235E, and the second polypeptide of the parent IgG class Fc region is the polypeptide of the IgG class parent Fc region with S228P, L235E mutations, or 8) первый полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG4 с мутациями S228P, L235E, P329G, и второй полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG4 с мутациями S228P, L235E, P329G, или8) the first polypeptide of the parent IgG class Fc region is a polypeptide of the human IgG4 Fc region with mutations S228P, L235E, P329G, and the second polypeptide of the parent IgG class Fc region is a polypeptide of the IgG class parent Fc region with mutations S228P, L235E, P329G , or 9) первый полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG4 с мутациями S228P, L235E, S354C, T366W, а второй полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG4 с мутациями S228P, L235E, Y349C, T366S, L368A, Y407V, или9) the first polypeptide of the parent Fc region of the IgG class is a polypeptide of the Fc region of human IgG4 with mutations S228P, L235E, S354C, T366W, and the second polypeptide of the parent Fc region of the IgG class is a polypeptide of the parent Fc region of IgG class with the mutations S228P, L235E , Y349C, T366S, L368A, Y407V, or 10) первый полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG4 с мутациями S228P, L235E, P329G, S354C, T366W, а второй полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG4 с мутациями S228P, L235E, P329G, Y349C, T366S, L368A, Y407V, или10) the first polypeptide of the parent IgG class Fc region is a polypeptide of the human IgG4 Fc region with mutations S228P, L235E, P329G, S354C, T366W, and the second polypeptide of the parent IgG class Fc region is a polypeptide of the human IgG4 Fc region with S228P mutations , L235E, P329G, Y349C, T366S, L368A, Y407V, or 11) первый полипептид родительской Fc-области класса IgG представляет 11) the first polypeptide of the parent IgG class Fc region is собой полипептид Fc-области человеческого IgG4 с мутациями S228P, L235E, P329G, Y349C, T366S, L368A, Y407V, илиa polypeptide of the Fc region of human IgG4 with mutations S228P, L235E, P329G, Y349C, T366S, L368A, Y407V, or 12) первый полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG1, IgG2 или IgG4 с мутацией K392D или первый полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG3 с мутацией N392D, а второй полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG1 с мутациями D399K, D356K и/или Е357K или второй полипептид родительской Fc-области класса IgG представляет собой полипептид Fc-области человеческого IgG2, IgG3 или IgG4 с мутациями D399K, Е356K и/или Е357K.12) the first polypeptide of the parent IgG class Fc region is a polypeptide of the Fc region of human IgG1, IgG2 or IgG4 with the K392D mutation, or the first polypeptide of the parent IgG class Fc region is the polypeptide of the human IgG3 Fc region with the mutation N392D, and the second polypeptide of the parent The IgG class Fc region is a human IgG1 Fc region polypeptide with mutations D399K, D356K and / or E357K, or the second IgG class Fc region polypeptide is a human IgG2, IgG3 or IgG4 Fc region polypeptide with mutations D399K, E356 K and / or E357K. 6. Антитело, содержащее Fc-область класса IgG по любому из пп. 1-5.6. The antibody containing the Fc region of the IgG class according to any one of paragraphs. 1-5. 7. Антитело по п. 6, где антитело представляет собой моноклональное антитело.7. The antibody of claim 6, wherein the antibody is a monoclonal antibody. 8. Антитело по любому из пп. 6-7, где антитело представляет собой человеческое, гуманизированное или химерное антитело.8. The antibody according to any one of paragraphs. 6-7, where the antibody is a human, humanized or chimeric antibody. 9. Антитело по любому из пп. 6-8, где антитело представляет собой биспецифичное антитело.9. The antibody according to any one of paragraphs. 6-8, where the antibody is a bispecific antibody. 10. Антитело по любому из пп. 6-9, где антитело представляет собой бивалентное антитело.10. The antibody according to any one of paragraphs. 6-9, where the antibody is a bivalent antibody. 11. Фармацевтическая композиция, содержащая антитело по любому из пп. 6-10.11. A pharmaceutical composition comprising an antibody according to any one of claims. 6-10. 12. Фармацевтическая композиция по п. 11, где фармацевтическая композиция предназначена для применения при лечении сосудистых заболеваний глаз.12. The pharmaceutical composition according to claim 11, where the pharmaceutical composition is intended for use in the treatment of vascular eye diseases. 13. Антитело по любому из пп. 6-10 для применения в качестве лекарственного средства.13. The antibody according to any one of paragraphs. 6-10 for use as a medicine. 14. Применение антитела по п. 13, где применение предназначено для лечения сосудистых заболеваний глаз.14. The use of antibodies according to claim 13, where the use is intended for the treatment of vascular eye diseases. 15. Применение антитела по любому из пп. 6-10 для изготовления лекарственного средства.15. The use of antibodies according to any one of paragraphs. 6-10 for the manufacture of a medicinal product.
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